Ex parte Bhide

When a specification states a utility (or "how to use") that corresponds in scope to the claimed subject matter, it must be taken as sufficient under 35 U.S.C. § 101 and the first paragraph of § 112 unless one skilled in the art has reason to question the objective truth of the statement or its scope. When prior art published before the filing date gives such a reason, the Board may sustain a § 101/§ 112 rejection, and the applicant may overcome it with suitable proofs (for example in vitro or in vivo evidence) that the stated utility and its scope are true. No prior Board precedent is named as being overruled. The decision applies the Langer, Brana and Marzocchi framework, which presumes a stated utility is true, to a Board-made rationale. For an examiner, a § 101/§ 112 utility rejection needs evidence that gives a reason to doubt the stated utility. The number of compounds claimed, differing reactivities, a small tested group, or the lack of in vitro or in vivo data does not suffice by itself. Here the Board built its own evidence from pre-filing references and made its affirmance a new ground of rejection under 37 CFR § 1.196(b). An applicant whose utility is questioned by pre-filing art must respond with evidence, and in vitro or in vivo tests are relevant but not the only route. The Board relied on In re Langer (CCPA 1974), In re Brana (Fed. Cir. 1995), In re Marzocchi (CCPA 1971), In re Glass (CCPA 1974), In re Jolles (CCPA 1980) and Newman v. Quigg (Fed. Cir. 1989). LEGAL TEST OR STANDARD: A specification with a description of utility that corresponds in scope to the claimed subject matter is taken as sufficient under § 101 for the entire claimed subject matter unless there is reason for one skilled in the art to question the objective truth of the statement of utility or its scope. If there is sufficient reason to question it, a § 101 rejection is proper. The same presumption and the same reason-to-doubt exception apply to the "how to use" requirement of § 112, first paragraph. Utility under § 101 is a question of fact. Compliance with the "how to use" requirement is a question of law. TRIGGERING FACTS: The claims were to substituted tetrapeptide compounds said to inhibit farnesyl protein transferase and treat cancer. Pre-filing publications (the Brown patent and publication, Reiss, and Glenn) indicated the fourth amino acid from the carboxy terminus must be cysteine, but the claimed compounds' fourth amino acid could not be cysteine. The specification had no in vitro or in vivo testing, and no 37 CFR § 1.132 evidence was offered. Other uses were stated only as possibilities and also appeared to require cysteine. KEY QUOTE: "A claim is not unpatentable under 35 U.S.C. § 101 or 35 U.S.C. § 112, first paragraph, merely because compounds within its scope have different reactivities." (Paper No. 12, p. 14) PRIOR PRECEDENT AFFECTED: No prior Board precedential or informative decision is directly affected. The Board applied Ex parte Forman, 230 USPQ 456, 457 (Bd. Pat. App. & Int. 1986), for the point that claim scope and the number of compounds are not irrelevant to a § 101 and/or § 112, first paragraph, analysis. It also followed In re Langer, 503 F.2d 1380 (CCPA 1974), and In re Brana, 51 F.3d 1560 (Fed. Cir. 1995). PRACTICE TIP: When pre-filing art gives a reason to question a stated utility, do not rely on argument or on the examiner's thin rationale. Submit evidence, such as in vitro or in vivo data in a 37 CFR § 1.132 declaration, showing that the stated utility and its full claimed scope are true. When the Board affirms on a new ground under 37 CFR § 1.196(b), use the offered window to reopen prosecution with that evidence.